Validation of a Predictive Model to Estimate the Risk o...

Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2 (CPM

Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2 (CPM)

This study is currently recruiting participants.
Verified by Association for Innovation and Biomedical Research on Light and Image, September 2008

Sponsors and Collaborators: Association for Innovation and Biomedical Research on Light and Image
Fundação para a Ciência e Tecnologia
Information provided by: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT00763802
Purpose

This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.

Condition
Diabetic Retinopathy

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetes Diabetic Eye Problems Edema Retinal Disorders

U.S. FDA Resources

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2

Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:

* CSME needing Photocoagulation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]


Secondary Outcome Measures:

* Vision Loss [ Time Frame: 24 months ] [ Designated as safety issue: No ]


Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment: 400
Study Start Date: September 2007
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
MNPDR
Type 2 diabetic patients with Mild non-prolipherative retinopathy.

Eligibility
Ages Eligible for Study: 35 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetic patients with Mild non-prolipherative retinopathy fulfilling the inclusion criterion.

Criteria

Inclusion Criteria:

* Diabetes type 2 according to 1985 WHO criteria.
* Age between 35 and 75 years.
* Mild non-prolipherative retinopathy (based on ETDRS criteria)
* Best Corrected Visual acuity >20 /25
* Refraction with a spherical equivalent less than 5 Dp.
* Inform consent

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations
* Glaucoma
* Vitreous syneresis or posterior vitreous detachment
* Other retinal vascular disease
* Recent intraocular surgery
* Previous laser therapy
* Dilatation of the pupil < 5 mm

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763802

Contacts
Contact: AIBILI SA
Contact: AIBILI CNTM seccntm@aibili.pt

Locations
Portugal
AIBILI Recruiting
Coimbra, Portugal, 3000-548
Contact: AIBILI CEC aibili@aibili.pt
Contact: AIBILI CNTM seccntm@aibili.pt
Principal Investigator: José G Cunha-Vaz, MD, PhD
Sub-Investigator: Conceição Lobo, MD, PhD

Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Fundação para a Ciência e Tecnologia

Investigators
Principal Investigator: José G Cunha-Vaz, MD, PhD Association for Innovation and Biomedical Research on Light and Image